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Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02454972
Recruitment Status : Active, not recruiting
First Posted : May 27, 2015
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Brief Summary:
Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: lurbinectedin (PM01183) Phase 2

Detailed Description:
Patients with relapsed small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) will be enrolled in nine different cohorts. Up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the SCLC cohort).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Actual Study Start Date : August 12, 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: lurbinectedin (PM01183)
lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
Drug: lurbinectedin (PM01183)



Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
    Overall response rate (ORR), defined as the percentage of evaluable patients with a confirmed response, either complete (CR) or partial (PR).


Secondary Outcome Measures :
  1. Duration of response (DR) [ Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
    Duration of response (DR), defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when disease progression (PD), recurrence or death is documented.

  2. Clinical Benefit [ Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
    Clinical benefit defined as patients with ORR or SD>=4 months

  3. Progression free survival (PFS) [ Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
    Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation.

  4. Overall survival (OS) in each cohort of advanced solid tumors [ Time Frame: infusion up to 12 months after last enrolled cohort patient received the first ]
    Defined as the period of time from the date of first infusion to the date of death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Voluntary signed informed consent (IC)
  • Pathologically proven diagnosis of any of the following malignancies:

    • Small cell lung cancer (SCLC).
    • Head and neck carcinoma (H&N). Salivary glands tumors are excluded.
    • Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health Organization classification.
    • Biliary tract carcinoma.
    • Endometrial carcinoma.
    • BRCA 1/2- associated metastatic breast carcinoma
    • Carcinoma of unknown primary site.
    • Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation.
    • Ewing's family of tumors (EFTs)
  • Prior treatment. Patients must have received:

    • SCLC, endometrial carcinoma: one prior chemotherapy-containing line.
    • H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines
    • GCTs: no limit of prior therapy
    • EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting.
    • BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines.
  • Performance status ≤ 2 [Eastern Cooperative Oncology Group (ECOG)]
  • Adequate major organ function
  • At least three weeks since the last chemotherapy
  • Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry

Exclusion Criteria:

  • Prior treatment with PM01183 or trabectedin
  • Prior or concurrent malignant disease unless in complete remission for more than five years
  • Known central nervous system (CNS) involvement
  • Relevant diseases or clinical situations which may increase the patient's risk
  • Pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454972


Locations
Show Show 39 study locations
Sponsors and Collaborators
PharmaMar
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02454972    
Other Study ID Numbers: PM1183-B-005-14
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Neoplasms